MUNICH — AstraZeneca has followed up on its breakthrough approval for Lynparza — the first of the PARP wave that arrived on the market 4 years ago — with the rollout of impressive frontline data for ovarian cancer.
Unlock this article along with other benefits by subscribing to one of our paid plans.
2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.
A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.
Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.
Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.
Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”
AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.
The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.
Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.
Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.
GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”
At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.
Sometimes, being late can give you an advantage.
That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.
As the US House Appropriations committee marks up a bill today to provide the FDA with a 10% budget boost in FY 2023, the committee also offered up a long wish list of topics that it wants the FDA to address.
The list ranges from urging CDER to better use artificial intelligence and machine learning to enhance its review process for supplements or repurposed drug candidates “by leveraging automated data collection, integration, and advanced statistical methods,” to encourage the FDA to publish guidance for cell therapy developers, to increasing staff in key areas.
Unlock this article along with other benefits by subscribing to one of our paid plans.
In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.
In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.
Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.
The Biden administration released its Spring regulatory agenda, offering up plans on which proposed and final rulemakings will be coming down the pike in the not-too-distant future.
For the FDA, many of the draft and final rules are repeats, although the agency will look to clear its plate of remaining 21st Century Cures Act obligations, which have been in the works since 2016.
For instance, although Section 3023 of the Cures Act has a Dec. 2019 statutory deadline, the agenda shows the FDA is still hoping to release two proposed rules related to that part of the bill this September.
Unlock this article along with other benefits by subscribing to one of our paid plans.